An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia

  • Interventional
  • Recruiting
  • NCT03604705
Eligibility Details Visit Clinicaltrials.gov

An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment

This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 to 80 years of age (inclusive). Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks. This study will be conducted at approximately 20 sites in the United States and globally.

Gender
All

Age Group
18 Years to 80 Years

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         - Provision of written consent

         - Ages 18-80 inclusive, male or female

         - New diagnosis of candidemia

         - Able to have pre-existing intravascular catheters removed and replaced (as necessary)

        Key Exclusion Criteria:

         - neutropenia

         - deep-seated Candida-related infections

         - hepatosplenic candidiasis

         - received more than 2 days of prior systemic antifungal treatment for current candidemia episode

         - severe hepatic impairment

At a Glance

National Government IDNCT03604705

IRB#IRB18-1079

Lead SponsorAmplyx Pharmaceuticals

Lead PhysicianKathleen Mullane

Collaborator(s)N/A

EligibilityAll
18 Years to 80 Years
Recruiting